Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT05956535
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Optix® Night and Day® Aqua Therapeutic Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004774', 'term': 'Entropion'}, {'id': 'D015715', 'term': 'Corneal Edema'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-14', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in corneal pain at the Follow-up Visit - Primary exposure', 'timeFrame': 'Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)', 'description': 'The Investigator will review the subject\'s chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bandage lens'], 'conditions': ['Bullous Keratopathy', 'Corneal Erosion', 'Entropion', 'Corneal Edema', 'Corneal Dystrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.', 'detailedDescription': "In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will enroll charts following a pre-identified process.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.\n* Baseline and Follow-up (up to 1 year from Baseline) charts available.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.\n* Used systemic or ocular medication that would confound study results during the data collection period.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05956535', 'briefTitle': 'Air Optix® Night and Day® Aqua Therapeutic Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Air Optix® Night and Day® Aqua Therapeutic Wear', 'orgStudyIdInfo': {'id': 'CLD265-N001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AONDA contact lenses', 'description': 'Lotrafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.', 'interventionNames': ['Device: Lotrafilcon A contact lenses']}, {'label': 'PV2 contact lenses', 'description': 'Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.', 'interventionNames': ['Device: Balafilcon A contact lenses']}], 'interventions': [{'name': 'Lotrafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['Air Optix® Night and Day® Aqua', 'AONDA'], 'description': 'CE-marked silicone hydrogel contact lenses', 'armGroupLabels': ['AONDA contact lenses']}, {'name': 'Balafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['PureVision® 2', 'PV2'], 'description': 'CE-marked silicone hydrogel contact lenses', 'armGroupLabels': ['PV2 contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Delray Physician Care Center', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Koetting Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center For Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, CRD Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}